BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBREKLEER 4X TAPERED POST

    MDR report key: 2471349 · Received February 28, 2012

    Report

    Report Number
    2024312-2012-00024
    Event Type
    Injury
    Date Received
    February 28, 2012
    Report Date
    January 31, 2012
    Manufacturer
    PENTRON CLINICAL
    Product Code
    ELR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR DID NOT DEFINITIVELY IDENTIFY THE SPECIFIC POSTS THAT WERE USED AND REFUSED TO GIVE ANY FURTHER INFORMATION. NONE OF THE POSTS INVOLVED IN THESE INCIDENTS WERE RETURNED. ALL OF THE RETURNED PRODUCTS WERE UNUSED AND OUT OF THEIR PACKAGE WITH NO LOT NUMBER OR EXPIRATION DATES AVAILABLE, THEREFORE, NO EVALUATION OR DHR REVIEW OF THE PRODUCTS COULD BE CONDUCTED. THE DOCTOR'S OFFICE WAS CONTACTED TO GET MORE INFORMATION REGARDING INCIDENT, BUT NO ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; HOWEVER, UNUSED FIBREKLEE 4X TAPERED POSTS FROM THREE (3) LOT NUMBERS (4290783, 4215148, AND 3800481) WERE RETURNED BY THE DOCTOR. THE DOCTOR COULD NOT IDENTIFY THE LOT NUMBER FOR THE FIBREKLEER POST THAT WAS USED ON THE PATIENT; THEREFORE IT CANNOT BE CONFIRMED THAT A POST FROM EITHER LOT NUMBER 4290783, 4215148, OR 380048 WAS NOT USED ON THE PATIENT. THE RETURNED PRODUCTS WERE VISUALLY INSPECTED AND WERE FOUND TO MEET PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT POSTS IN TWO PATIENTS HAD BROKEN. THIS IS 1ST OF THE TWO MDRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBREKLEER 4X TAPERED POST ROOT CANAL POST ELR PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other